CRL for daclatasvir sets back BMS's HCV program

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA issued a complete response letter for daclatasvir on Wednesday, requesting additional safety and efficacy data for the HCV drug in combination with other antiviral agents. BMS said its NDA for the selective HCV NS5A protein inhibitor focused on its combination with asunaprevir, an HCV NS3 protease inhibitor. Last month, BMS withdrew an NDA for asunaprevir and said it would no longer pursue approval of a combination of the two direct-acting antivirals (see BioCentury Extra, Oct. 7).

Company spokesperson Carrie Fernandez told BioCentury BMS anticipates resubmitting the NDA with additional data from completed and ongoing trials without performing additional studies, although it is still discussing with FDA the scope of the data necessary for resubmission. She declined to say which new combinations BMS might include in its resubmission, or give a specific timeline for resubmission. ...